Review Reports: Drugs

The following English translations of review reports are intended to be a reference material to provide convenience for users. In the event of inconsistency between the Japanese originals and the translations, the former shall prevail. PMDA shall not be responsible for any consequence resulting from use of the English versions.

The review reports were selected for translation among those of drugs with a new active ingredient that recently received marketing approval, in consideration of relevant factors including the novelty and priority.

Browse by letter

A	B	C	D	E	F	G
H	I	J	K	L	M	N
O	P	Q	R	S	T	U
V	W	X	Y	Z

A

Brand Name	Non-proprietary Name	Approved In	English	Japanese
Abraxane Partial Change Approval	Paclitaxel	September  2019
Acoalan	Antithrombin gamma (genetical recombination)	July 2015
Acofide	Acotiamide hydrochloride hydrate	March 2013
Actair	-	March 2015		1.  2.
Actemra Initial Approval	Tocilizumab (genetical recombination)	April 2008		1. 2.
Actemra Partial Change Approval	Tocilizumab (genetical recombination)	June 2017
Actemra Partial Change Approval	Tocilizumab (genetical recombination)	August 2017
Actemra Partial Change Approval	Tocilizumab (genetical recombination)	May 2019
Actemra Partial Change Approval	Tocilizumab (genetical recombination)	January 2022
Adcetris Initial Approval	Brentuximab vedotin (genetical recombination)	January 2014
Adcetris Partial Change Approval	Brentuximab vedotin (genetical recombination)	September 2018
Adcetris Partial Change Approval	Brentuximab vedotin (genetical recombination)	December 2019
Adempas	Riociguat	January 2014
Adlumiz	Anamorelin hydrochloride	January 2021
Adsorbed Cell Culture-derived Influenza Vaccine H5N1 "Kitasato Daiichi Sankyo"	Adsorbed cell culture-derived influenza vaccine (H5N1)	March 2016
Adsorbed Influenza Vaccine (H5N1)  "HOKKEN"	Adsorbed influenza vaccine (H5N1)	October 2007		1. 2. 3.
Adsorbed Influenza Vaccine (H5N1)  "BIKEN"	Adsorbed influenza vaccine (H5N1)	October 2007		1. 2. 3.
Adynovate	Rurioctocog alfa pegol (genetical recombination)	March 2016
Afstyla	Lonoctocog alfa (genetical recombination)	September 2017
Akalux	Cetuximab sarotalocan sodium (genetical recombination)	September 2020
Alabel/Alaglio	Aminolevulinic acid hydrochloride	March 2013
Alecensa	Alectinib hydrochloride	July 2014
Allergen Scratch Extract Positive control "TORII" Histamine Dihydrochloride	Histamine dihydrochloride	September 2015
Amenalief	Amenamevir	July 2017
Anoro Ellipta	Umeclidinium bromide/ vilanterol trifenatate	July 2014
Artist	Carvedilol	August 2015
Avastin Initial Approval	Bevacizumab (genetical recombination)	April 2007		1. 2. 3. 4. 5. 6.
Avastin Partial Change Approval	Bevacizumab (genetical recombination)	May 2016
Avigan	Favipiravir	March 2014

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B

Brand Name	Non-proprietary Name	Approved In	English	Japanese
Bavencio	Avelumab (genetical recombination)	September 2017
Benlysta Initial Approval	Belimumab (genetical recombination)	September 2017
Benlysta Partial Change Approval	Belimumab (genetical recombination)	September 2019
Betanis	Mirabegron	June 2011
Bevespi Aerosphere	Glycopyrronium bromide/formoterol fumarate hydrate	June 2019
Biktarvy	Bictegravir sodium/emtricitabine/tenofovir alafenamide fumarate	March 2019
Botox	Botulinum toxin type A	June 2015
Braftovi Initial Approval	Encorafenib	January 2019
Braftovi Partial Change Approval	Encorafenib	November 2020
Breztri Aerosphere	Budesonide/glycopyrronium bromide/formoterol fumarate hydrate	June 2019
Bridion	Sugammadex sodium	January 2010

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C

Brand Name	Non-proprietary Name	Approved In	English	Japanese
Cablivi	Caplacizumab (genetical recombination)	September 2022
Cerdartolen	-	January 2014
Cerdelga	Eliglustat tartrate	March 2015		(Note 1)
Cervarix	Recombinant adsorbed bivalent human papillomavirus-like particle vaccine (derived from Trichoplusia ni cell)	October 2009
Cibinqo	Abrocitinib	September 2021
Clenafin	Efinaconazole	July 2014
Clozaril	Clozapine	April 2009
Comirnaty(Note 2) (monovalent, Original) Initial Approval	Coronavirus Modified Uridine RNA Vaccine (SARS-CoV-2) (active ingredient: tozinameran)	February 2021
Comirnaty(Note 2) (monovalent, Original) Partial Change Approval	Coronavirus Modified Uridine RNA Vaccine (SARS-CoV-2) (active ingredient: tozinameran)	November 2021
Comirnaty RTU(Note 2) (bivalent, Original/Omicron BA.1) Partial Change Approval	Coronavirus Modified Uridine RNA Vaccine (SARS-CoV-2) (active ingredients: tozinameran and riltozinameran)	September 2022		(Note 1)
Comirnaty RTU(Note 2) (bivalent, Original/Omicron BA.4-5) Partial Change Approval	Coronavirus Modified Uridine RNA Vaccine (SARS-CoV-2) (active ingredients: tozinameran and famtozinameran)	August 2023		(Note 1)
Comirnaty for 5 to 11 years old(Note 2) (monovalent, Original) Initial Approval	Coronavirus Modified Uridine RNA Vaccine (SARS-CoV-2) (active ingredient: tozinameran)	January 2022
Comirnaty for 5 to 11 years old(Note 2) (monovalent, Original) Partial Change Approval	Coronavirus Modified Uridine RNA Vaccine (SARS-CoV-2) (active ingredient: tozinameran)	August 2022		(Note 1)
Comirnaty for 5 to 11 years old(Note 2) (bivalent, Original/Omicron BA.4-5) Partial Change Approval	Coronavirus Modified Uridine RNA Vaccine (SARS-CoV-2) (active ingredients: tozinameran and famtozinameran)	February 2023
Comirnaty for 5 to 11 years old(Note 2) (bivalent, Original/Omicron BA.4-5) Partial Change Approval	Coronavirus Modified Uridine RNA Vaccine (SARS-CoV-2) (active ingredients: tozinameran and famtozinameran)	August 2023		(Note 1)
Comirnaty for 6 months to 4 years old(Note 2) (monovalent, Original) Initial Approval	Coronavirus Modified Uridine RNA Vaccine (SARS-CoV-2) (active ingredient: tozinameran)	October 2022
Comirnaty for 6 months to 4 years old(Note 2) (bivalent, Original/Omicron BA.4-5) Partial Change Approval	Coronavirus Modified Uridine RNA Vaccine (SARS-CoV-2) (active ingredients: tozinameran and famtozinameran)	August 2023		(Note 1)
Copegus Partial Change Approval	Ribavirin	March 2015
Copegus Partial Change Approval	Ribavirin	March 2017
Corectim	Delgocitinib	January 2020
Cosentyx Initial Approval	Secukinumab (genetical recombination)	December 2014
Cosentyx Partial Change Approval	Secukinumab (genetical recombination)	December 2015
Crysvita	Burosumab (genetical recombination)	September 2019
Cymbalta Partial Change Approval	Duloxetine hydrochloride	December 2016
Cyramza Initial Approval	Ramucirumab (genetical recombination)	March 2015
Cyramza Partial Change Approval	Ramucirumab (genetical recombination)	May 2016
Cyramza Partial Change Approval	Ramucirumab (genetical recombination)	June 2016

^{Note 1} Errata sheet. The English translation has been corrected accordingly.
^{Note 2} Special Approval for Emergency

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D

Brand Name	Non-proprietary Name	Approved In	English	Japanese
Daichirona (monovalent, Original)	Coronavirus (SARS-CoV-2) RNA Vaccine (active ingredient: ufrenmeran)	August 2023
Daklinza	Daclatasvir hydrochloride	July 2014
Darvias	Darinaparsin	June 2022
Darzalex Initial Approval	Daratumumab (genetical recombination)	September 2017
Darzalex Partial Change Approval	Daratumumab (genetical recombination)	August 2019
Dayvigo	Lemborexant	January 2020		1. 2.
Deltyba	Delamanid	July 2014
Diquas	Diquafosol sodium	April 2010		1. 2.
Duac	Clindamycin phosphate hydrate/benzoyl peroxide	March 2015
Dupixent	Dupilumab (genetical recombination)	January 2018
Dysval	Valbenazine tosilate	March 2022

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E

Brand Name	Non-proprietary Name	Approved In	English	Japanese
Efient	Prasugrel hydrochloride	March 2014		1.  2.
Eliquis	Apixaban	December 2012		(Note 1)
Emgality	Galcanezumab (genetical recombination)	January 2021
Empliciti	Elotuzumab (genetical recombination)	September 2016
Emulsion-adjuvanted Cell-culture Derived Influenza HA Vaccine (Prototype) for Intramuscular Injection "KAKETSUKEN"	Emulsion-adjuvanted cell-culture derived influenza HA vaccine (prototype)	March 2015
Enaroy	Enarodustat	September 2020
Enhertu Initial Approval	Trastuzumab deruxtecan (genetical recombination)	March 2020
Enhertu Partial Change Approval	Trastuzumab deruxtecan (genetical recombination)	September 2020
Enspryng	Satralizumab (genetical recombination)	June 2020		(Note 1)
Epoprostenol ACT Partial Change Approval	Epoprostenol sodium	March 2017
Erelsa	Elbasvir	September 2016
Erleada	Apalutamide	March 2019
Evenity	Romosozumab (genetical recombination)	January 2019
Evrenzo	Roxadustat	September 2019
Evusheld(Note 2)	Tixagevimab (genetical recombination) and cilgavimab (genetical recombination)	August 2022
Eylea Partial Change Approval	Aflibercept (genetical recombination)	June 2015
Eylea Partial Change Approval	Aflibercept (genetical recombination)	September 2022

^{Note 1} Errata sheet. The English translation has been corrected accordingly.
^{Note 2} Special Approval for Emergency

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F

Brand Name	Non-proprietary Name	Approved In	English	Japanese
Farydak	Panobinostat lactate	July 2015
Fasenra	Benralizumab (genetical recombination)	January 2018
Feburic Initial Approval	Febuxostat	January 2011
Feburic Partial Change Approval	Febuxostat	May 2016
Forteo	Teriparatide (genetical recombination)	July 2010
Forxiga Initial Approval	Dapagliflozin propylene glycolate hydrate	March 2014
Forxiga Partial Change Approval	Dapagliflozin propylene glycolate hydrate	November 2020
Freeze-dried Smallpox Vaccine Prepared in Cell Culture LC16 “KMB” Partial Change Approval	Freeze-dried smallpox vaccine prepared in cell culture	August 2022

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G

Brand Name	Non-proprietary Name	Approved In	English	Japanese
Galafold	Migalastat hydrochloride	March 2018
Geninax	Garenoxacin mesilate hydrate	July 2007		1. 2.
Genvoya	Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide fumarate	June 2016
Giotrif	Afatinib maleate	January 2014
Goofice	Elobixibat hydrate	January 2018		1. 2.
Grazyna	Grazoprevir hydrate	September 2016

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H

Brand Name	Non-proprietary Name	Approved In	English	Japanese
Halaven Initial Approval	Eribulin mesilate	April 2011
Halaven Partial Change Approval	Eribulin mesilate	February 2016
Harvoni	Ledipasvir acetonate/sofosbuvir	July 2015
Hemangiol	Propranolol hydrochloride	July 2016
Hemlibra	Emicizumab (genetical recombination)	March 2018
Herceptin Partial Change Approval	Trastuzumab (genetical recombination)	March 2022		(Note 1)
Hiyasta	Tucidinostat	June 2021		1. 2. (Note 1)
Humira Partial Change Approval	Adalimumab (genetical recombination)	September 2016

^{Note 1} Errata sheet. The English translation has been corrected accordingly.

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I

Brand Name	Non-proprietary Name	Approved In	English	Japanese
Idelvion	Albutrepenonacog alfa (genetical recombination)	September 2016
Ilaris Partial Change Approval	Canakinumab (genetical recombination)	December 2016
Imbruvica Partial Change Approval	Ibrutinib	February 2023
Imfinzi Initial Approval	Durvalumab (genetical recombination)	July 2018
Imfinzi Partial Change Approval	Durvalumab (genetical recombination)	August 2020
Inavir Initial Approval	Laninamivir octanoate hydrate	September 2010
Inavir Partial Change Approval	Laninamivir octanoate hydrate	December 2013
Inavir Partial Change Approval	Laninamivir octanoate hydrate	August 2016
Inavir Partial Change Approval	Laninamivir octanoate hydrate	June 2019
Insulin Glargine BS [Lilly]	Insulin glargine (genetical recombination) [insulin glargine biosimilar 1]	December 2014
Intuniv Partial Change Approval	Guanfacine hydrochloride	June 2019
Irribow	Ramosetron hydrochloride	May 2015
Isentress	Raltegravir potassium	June 2008
Istodax	Romidepsin	July 2017
Izcargo	Pabinafusp alfa (genetical recombination)	March 2021

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J

Brand Name	Non-proprietary Name	Approved In	English	Japanese
Januvia/Glactiv	Sitagliptin phosphate hydrate	October 2009		1. 2.
Jcovden	COVID-19 (SARS-CoV-2) Vaccine (recombinant adenovirus vector)	June 2022		(Note 1)
Jeselhy	Pimitespib	June 2022
Jivi	Damoctocog alfa pegol (genetical recombination)	September 2018
Jyseleca	Filgotinib maleate	September 2020

^{Note 1} Errata sheet. The English translation has been corrected accordingly.

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K

Brand Name	Non-proprietary Name	Approved In	English	Japanese
Kadcyla	Trastuzumab emtansine (genetical recombination)	September 2013
Kanuma	Sebelipase alfa (genetical recombination)	March 2016
Kenketu Glovenin-I Partial Change Approval	Freeze-dried polyethylene glycol-treated human normal immunoglobulin	November 2015
Kenketu Glovenin-I Partial Change Approval	Freeze-dried polyethylene glycol-treated human normal immunoglobulin	September 2016
Kerendia	Finerenone	March 2022
Kevzara	Sarilumab (genetical recombination)	September 2017
Keytruda Initial Approval	Pembrolizumab (genetical recombination)	September 2016
Keytruda Partial Change Approval	Pembrolizumab (genetical recombination)	December 2016
Keytruda Partial Change Approval	Pembrolizumab (genetical recombination)	December 2018
Keytruda Partial Change Approval	Pembrolizumab (genetical recombination)	August 2020		(Note 1)
Kyprolis	Carfilzomib	July 2016

^{Note 1} Errata sheet. The English translation has been corrected accordingly.

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L

Brand Name	Non-proprietary Name	Approved In	English	Japanese
Lagevrio(Note 2)	Molnupiravir	December 2021
Laserphyrin	Talaporfin sodium	May 2015
Lenvima Initial Approval	Lenvatinib mesilate	March 2015		1.  2.  3.  4.
Lenvima Partial Change Approval	Lenvatinib mesilate	March 2018		1. 2.
Lenvima Partial Change Approval	Lenvatinib mesilate	March 2021
Leqembi	Lecanemab (genetical recombination)	September 2023		1.  2.  3.  4.
Libtayo	Cemiplimab (genetical recombination)	December 2022
Litfulo	Ritlecitinib tosilate	June 2023
Livalo	Pitavastatin calcium hydrate	June 2015
Lixiana	Edoxaban	April 2011		(Note 1)
Lonasen Partial Change Approval	Blonanserin	March 2021
Lonsurf Initial Approval	Trifluridine and tipiracil hydrochloride	March 2014
Lonsurf Partial Change Approval	Trifluridine and tipiracil hydrochloride	August 2019
Loqoa	Esflurbiprofen/mentha oil	September 2015
Lorbrena	Lorlatinib	September 2018
Lumicef	Brodalumab (genetical recombination)	July 2016
Lyfnua	Gefapixant citrate	January 2022		1. 2.
Lytgobi	Futibatinib	June 2023	Review Report [1.26 MB]	Review Report [1.46 MB]
Lyxumia	Lixisenatide	June 2013

^{Note 1} Errata sheet. The English translation has been corrected accordingly.
^{Note 2} Special Approval for Emergency

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M

Brand Name	Non-proprietary Name	Approved In	English	Japanese
Macugen	Pegaptanib sodium	July 2008
Maviret	Glecaprevir hydrate/pibrentasvir	September 2017
Mayzent	Siponimod fumaric acid	June 2020		(Note 1)
Mekinist Initial Approval	Trametinib dimethyl sulfoxide	March 2016
Mekinist Partial Change Approval	Trametinib dimethyl sulfoxide	March 2018
Mekinist Partial Change Approval	Trametinib dimethyl sulfoxide	July 2018
Mektovi Initial Approval	Binimetinib	January 2019
Mektovi Partial Change Approval	Binimetinib	November 2020
Memary	Memantine hydrochloride	January 2011
Metreleptin	Metreleptin (genetical recombination)	March 2013
Mikeluna	Carteolol hydrochloride/ latanoprost	September 2016
Minnebro	Esaxerenone	January 2019
Mitchga	Nemolizumab (genetical recombination)	March 2022
Miticure	-	September 2015
Moizerto	Difamilast	September 2021
Mulpleta	Lusutrombopag	September 2015		1. 2.
Mundesine	Forodesine hydrochloride	March 2017
Myozyme	Alglucosidase alfa (genetical recombination)	April 2007		1. 2.

^{Note 1} Errata sheet. The English translation has been corrected accordingly.

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N

Brand Name	Non-proprietary Name	Approved In	English	Japanese
Ninlaro	Ixazomib citrate	March 2017
Nopicor	Nalfurafine hydrochloride	December 2014
Nouriast	Istradefylline	March 2013
NovoEight	Turoctocog alfa (genetical recombination)	January 2014
NovoThirteen	Catridecacog (genetical recombination)	March 2015
Nubeqa	Darolutamide	January 2020
Nucala	Mepolizumab (genetical recombination)	March 2016
Nuvaxovid	Recombinant Coronavirus (SARS-CoV-2) Vaccine	April 2022

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O

Brand Name	Non-proprietary Name	Approved In	English	Japanese
Ofev Initial Approval	Nintedanib ethanesulfonate	July 2015
Ofev Partial Change Approval	Nintedanib ethanesulfonate	May 2020
Olanedine	Olanexidine gluconate	July 2015
Olumiant Initial Approval	Baricitinib	July 2017
Olumiant Partial Change Approval	Baricitinib	December 2020
Olumiant Partial Change Approval	Baricitinib	April 2021
Omvoh	Mirikizumab (genetical recombination)	March 2023
Ongentys	Opicapone	June 2020
Opdivo Initial Approval	Nivolumab (genetical recombination)	July 2014
Opdivo Partial Change Approval	Nivolumab (genetical recombination)	December 2015
Opdivo Partial Change Approval	Nivolumab (genetical recombination)	August 2016
Opdivo Partial Change Approval	Nivolumab (genetical recombination)	December 2016
Opdivo Partial Change Approval	Nivolumab (genetical recombination)	March 2017
Opdivo Partial Change Approval	Nivolumab (genetical recombination)	September 2017
Opdivo Partial Change Approval	Nivolumab (genetical recombination)	May 2018
Opdivo Partial Change Approval	Nivolumab (genetical recombination)	August 2018
Opdivo Partial Change Approval	Nivolumab (genetical recombination)	February 2020
Opdivo Partial Change Approval	Nivolumab (genetical recombination)	September 2020
Opdivo Partial Change Approval	Nivolumab (genetical recombination)	November 2021
Orencia	Abatacept (genetical recombination)	July 2010
Orfadin	Nitisinone	December 2014
Orkedia Initial Approval	Evocalcet	March 2018
Orkedia Partial Change Approval	Evocalcet	December 2019
Orladeyo	Berotralstat hydrochloride	January 2021
Ostabalo	Abaloparatide acetate	March 2021
Otezla	Apremilast	December 2016

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P

Brand Name	Non-proprietary Name	Approved In	English	Japanese
Parmodia	Pemafibrate	July 2017
Parmodia XR	Pemafibrate	June 2023
Parsabiv	Etelcalcetide hydrochloride	December 2016
Paxlovid(Note 2)	Nirmatrelvir and ritonavir	February 2022
Perjeta Initial Approval	Pertuzumab (genetical recombination)	June 2013		(Note 1)
Perjeta Partial Change Approval	Pertuzumab (genetical recombination)	March 2022		(Note 1)
Pirespa	Pirfenidone	October 2008
Pivlaz	Clazosentan sodium	January 2022
Pomalyst	Pomalidomide	March 2015
Poteligeo Initial Approval	Mogamulizumab (genetical recombination)	March 2012
Poteligeo Partial Change Approval	Mogamulizumab (genetical recombination)	August 2018
Pradaxa	Dabigatran etexilate methanesulfonate	January 2011
Pralia Partial Change Approval	Denosumab (genetical recombination)	July 2017
Praluent	Alirocumab (genetical recombination)	July 2016		(Note 1)
Precedex Partial Change Approval	Dexmedetomidine hydrochloride	February 2023		(Note 1)
Prevymis	Letermovir	March 2018
Prizbind	Idarucizumab (genetical recombination)	September 2016
Proemend	Fosaprepitant meglumine	March 2016

^{Note 1} Errata sheet. The English translation has been corrected accordingly.
^{Note 2} Special Approval for Emergency

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Q

Brand Name	Non-proprietary Name	Approved In	English	Japanese
Quattrovac	Adsorbed diphtheria-purified pertussis-tetanus-inactivated polio (Sabin strain) combined vaccine	July 2012		1. 2.

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R

Brand Name	Non-proprietary Name	Approved In	English	Japanese
Radicut	Edaravone	June 2015
Rapalimus (tablet)	Sirolimus	July 2014
Rapalimus (topical gel)	Sirolimus	March 2018
Rapiacta	Peramivir hydrate	January 2010
Rasilez	Aliskiren fumarate	July 2009
Rasuritek	Rasburicase (genetical recombination)	October 2009
Rebetol Partial Change Approval	Ribavirin	September 2016
Rebetol Partial Change Approval	Ribavirin	March 2017
Refixia	Nonacog beta pegol (genetical recombination)	July 2018
Regroth	Trafermin (genetical recombination)	September 2016
Relumina	Relugolix	January 2019
Remicade	Infliximab (genetical recombination)	August 2015
Remitch	Nalfurafine hydrochloride	January 2009
Repatha	Evolocumab (genetical recombination)	January 2016
Revcovi	Elapegademase (genetical recombination)	March 2019
Revlimid Partial Change Approval	Lenalidomide hydrate	March 2017
Revolade Initial Approval	Eltrombopag olamine	October 2010
Revolade Partial Change Approval	Eltrombopag olamine	August 2017
Rinvoq Partial Change Approval	Upadacitinib hydrate	September 2021
Risperdal	Risperidone	February 2016
Rituxan Partial Change Approval	Rituximab (genetical recombination)	August 2014
Rituxan Partial Change Approval	Rituximab (genetical recombination)	June 2022
Romiplate Initial Approval	Romiplostim (genetical recombination)	January 2011
Romiplate Partial Change Approval	Romiplostim (genetical recombination)	June 2019
Ronapreve(Note 2) Initial Approval	Casirivimab (genetical recombination) and imdevimab (genetical recombination)	July 2021
Ronapreve(Note 2) Partial Change Approval	Casirivimab (genetical recombination) and imdevimab (genetical recombination)	November 2021
Rosuzet	Ezetimibe / rosuvastatin calcium	March 2019
Rozerem	Ramelteon	April 2010
Rozlytrek	Entrectinib	June 2019
Ryzodeg	Insulin degludec (genetical recombination) / insulin aspart (genetical recombination)	December 2012

^{Note 2} Special Approval for Emergency

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S

Brand Name	Non-proprietary Name	Approved In	English	Japanese
Samsca	Tolvaptan	March 2014
Samtasu	Tolvaptan sodium phosphate	March 2022
Sarclisa	Isatuximab (genetical recombination)	June 2020
Seebri	Glycopyrronium bromide	September 2012
Shingrix	Dried recombinant herpes zoster vaccine (derived from Chinese hamster ovary cells)	March 2018
Signifor Partial Change Approval	Pasireotide pamoate	March 2018
Skyrizi	Risankizumab (genetical recombination)	March 2019
Smyraf	Peficitinib hydrobromide	March 2019
Soliris Initial Approval	Eculizumab (genetical recombination)	April 2010
Soliris Partial Change Approval	Eculizumab (genetical recombination)	December 2017
Sovaldi Initial Approval	Sofosbuvir	March 2015
Sovaldi Partial Change Approval	Sofosbuvir	March 2017
Sovriad	Simeprevir sodium	September 2013
Spikevax (previously COVID-19 Vaccine Moderna)(Note 2) (monovalent, Original) Initial Approval	Coronavirus Modified Uridine RNA Vaccine (SARS-CoV-2) (active ingredient: elasomeran)	May 2021
Spikevax (previously COVID-19 Vaccine Moderna)(Note 2) (monovalent, Original) Partial Change Approval	Coronavirus Modified Uridine RNA Vaccine (SARS-CoV-2) (active ingredient: elasomeran)	December 2021
Spikevax (previously COVID-19 Vaccine Moderna)(Note 2) (bivalent, Original/Omicron BA.1)	Coronavirus Modified Uridine RNA Vaccine (SARS-CoV-2) (active ingredients: elasomeran and imelasomeran)	September 2022		(Note 1)
Spinraza Initial Approval	Nusinersen sodium	July 2017
Spinraza Partial Change Approval	Nusinersen sodium	September 2017
Spiolto	Tiotropium bromide hydrate/olodaterol hydrochloride	September 2015
Squarekids	Adsorbed diphtheria-purified pertussis-tetanus-inactivated polio (salk vaccine) combined vaccine	July 2014
Steboronine	Borofalan (10B)	March 2020
Stelara Initial Approval	Ustekinumab (genetical recombination)	December 2010
Stelara Partial Change Approval	Ustekinumab (genetical recombination)	March 2017
Stivarga Initial Approval	Regorafenib hydrate	March 2013
Stivarga Partial Change Approval	Regorafenib hydrate	June 2017
Strensiq	Asfotase alfa (genetical recombination)	July 2015
Stribild	Elvitegravir/cobicistat/ emtricitabine/tenofovir disoproxil fumarate	March 2013
Suglat Initial Approval	Ipragliflozin L-proline	January 2014
Suglat Partial Change Approval	Ipragliflozin L-proline	December 2018
Suiny	Anagliptin	December 2015
Sunvepra	Asunaprevir	July 2014
Symproic	Naldemedine tosilate	March 2017
Synflorix	Pneumococcal 10-valent conjugate vaccine adsorbed (non-typeable haemophilus influenzae [NTHi] protein D, diphtheria or tetanus toxoid conjugates)	March 2015

^{Note 1} Errata sheet. The English translation has been corrected accordingly.
^{Note 2} Special Approval for Emergency

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T

Brand Name	Non-proprietary Name	Approved In	English	Japanese
Tabrecta	Capmatinib hydrochloride hydrate	June 2020
Tafinlar Initial Approval	Dabrafenib mesilate	March 2016
Tafinlar Partial Change Approval	Dabrafenib mesilate	March 2018
Tafinlar Partial Change Approval	Dabrafenib mesilate	July 2018
Tagrisso	Osimertinib mesilate	March 2016
Takecab	Vonoprazan fumarate	December 2014
Takelda	Aspirin/lansoprazole	March 2014
Talion	Bepotastine besilate	May 2015
Taltz	Ixekizumab (genetical recombination)	July 2016
Tavneos	Avacopan	September 2021
Tazverik	Tazemetostat hydrobromide	June 2021		1. 2. 3.
Tecentriq Initial Approval	Atezolizumab (genetical recombination)	January 2018
Tecentriq Partial Change Approval	Atezolizumab (genetical recombination)	August 2019
Tecentriq Partial Change Approval	Atezolizumab (genetical recombination)	September 2019
Tecentriq Partial Change Approval	Atezolizumab (genetical recombination)	November 2019
Tenelia	Teneligliptin hydrobromide hydrate	June 2012
Tepmetko	Tepotinib hydrochloride hydrate	March 2020
Tetrabik	Adsorbed diphtheria-purified pertussis-tetanus-inactivated polio (Sabin strain) combined vaccine	July 2012		1. 2.
Thaled Initial Approval	Thalidomide	October 2008
Thaled Partial Change Approval	Thalidomide	February 2021
Tivicay	Dolutegravir sodium	March 2014
Topiloric/Uriadec	Topiroxostat	June 2013
Topina	Topiramate	July 2007
Tracleer (pediatric dispersible tablets)	Bosentan hydrate	September 2015
Treakisym Partial Change Approval	Bendamustine hydrochloride	December 2016
Tremfya	Guselkumab (genetical recombination)	March 2018
Trerief Initial Approval	Zonisamide	January 2009
Trerief Partial Change Approval	Zonisamide	July 2018
Tresiba Initial Approval	Insulin degludec (genetical recombination)	September 2012
Tresiba Partial Change Approval	Insulin degludec (genetical recombination)	August 2015
TS-1 Partial Change Approval	Tegafur/gimeracil/oteracil potassium	November 2022
Twymeeg	Imeglimin hydrochloride	June 2021

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U

Brand Name	Non-proprietary Name	Approved In	English	Japanese
Uptravi	Selexipag	September 2016

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V

Brand Name	Non-proprietary Name	Approved In	English	Japanese
Vafseo	Vadadustat	June 2020
Vanflyta	Quizartinib hydrochloride	June 2019
Vaxzevria(Note 2)	COVID-19 (SARS-CoV-2) Vaccine (recombinant chimpanzee adenovirus vector)	May 2021		(Note 1)
Veklury(Note 2)	Remdesivir	May 2020		(Note 1)
Velcade Partial Change Approval	Bortezomib	August 2019
Velexbru Initial Approval	Tirabrutinib hydrochloride	March 2020
Velexbru Partial Change Approval	Tirabrutinib hydrochloride	August 2020		(Note 1)
Vemlidy	Tenofovir alafenamide fumarate	December 2016
Verquvo	Vericiguat	June 2021
Victoza	Liraglutide (genetical recombination)	January 2010
Viekirax Initial Approval	Ombitasvir hydrate/paritaprevir hydrate/ritonavir	September 2015
Viekirax Partial Change Approval	Ombitasvir hydrate/paritaprevir hydrate/ritonavir	September 2016
Viltepso	Viltolarsen	March 2020
Vizimpro	Dacomitinib hydrate	January 2019
Volibris Partial Change Approval	Ambrisentan	March 2021
Votrient	Pazopanib hydrochloride	September 2012
Vyndaqel Initial Approval	Tafamidis meglumine	September 2013
Vyndaqel Partial Change Approval	Tafamidis meglumine	March 2019		(Note 1)
Vyvgart	Efgartigimod alfa (genetical recombination)	January 2022

^{Note 1} Errata sheet. The English translation has been corrected accordingly.
^{Note 2} Special Approval for Emergency

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W

Brand Name	Non-proprietary Name	Approved In	English	Japanese
Wegovy	Semaglutide (genetical recombination)	March 2023

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X

Brand Name	Non-proprietary Name	Approved In	English	Japanese
Xalkori Initial Approval	Crizotinib	March 2012
Xalkori Partial Change Approval	Crizotinib	May 2017
Xarelto Partial Change Approval	Rivaroxaban	January 2021
Xeljanz Initial Approval	Tofacitinib citrate	March 2013
Xeljanz Partial Change Approval	Tofacitinib citrate	May 2018
Xenpozyme	Olipudase alfa (genetical recombination)	March 2022
Xevudy(Note 2)	Sotrovimab (genetical recombination)	September 2021		(Note 1)
Xiaflex	Collagenase (clostridium histolyticum)	July 2015
Ximency	Daclatasvir hydrochloride/asunaprevir/beclabuvir hydrochloride	December 2016
Xocova(Note 3)	Ensitrelvir fumaric acid	November 2022
Xofluza Initial Approval	Baloxavir marboxil	February 2018		1. 2. 3.
Xofluza Partial Change Approval	Baloxavir marboxil	November 2020
Xolair	Omalizumab (genetical recombination)	January 2009
Xospata	Gilteritinib fumarate	September 2018

^{Note 1} Errata sheet. The English translation has been corrected accordingly.
^{Note 2} Special Approval for Emergency
^{Note 3} Emergency Approval

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Y

Brand Name	Non-proprietary Name	Approved In	English	Japanese
Yervoy Initial Approval	Ipilimumab (genetical recombination)	July 2015
Yervoy Partial Change Approval	Ipilimumab (genetical recombination)	May 2018
Yervoy Partial Change Approval	Ipilimumab (genetical recombination)	August 2018
Yervoy Partial Change Approval	Ipilimumab (genetical recombination)	September 2020
Yondelis	Trabectedin	September 2015

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Z

Brand Name	Non-proprietary Name	Approved In	English	Japanese
Zafatek	Trelagliptin succinate	March 2015
Zagallo	Dutasteride	September 2015
Zejula	Niraparib tosilate hydrate	September 2020		1. 2. 3.
Zetia	Ezetimibe	April 2007
Zykadia	Ceritinib	March 2016
Zyprexa/Olanzapine	Olanzapine	December 2017

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